Straumann Palatal Implant , 04.1 L 4.2 mm recallZ-0277-2008 · Straumann USA LLC · initiated Sep 28, 2007
Terminated All recalls posted in December 2007
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Straumann USA LLC or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Sticking Transfer Piece: The Transfer Piece which accompanies the Palatal Implant may get stuck during implant requiring removal by using mechanical force.
FDA root cause category: Device Design
What the company is doing
Straumann USA, LLC sent Urgent Device Recall letters, via FedFx on 9/28/07, requesting the return of all Straumann Palatal Implant, articles 042.335 with lot numbers 1001, FE3776, F4662, F6563, E7083, and article 042.336S lot number 1001.
Recall details
- Recall number
- Z-0277-2008
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Sep 28, 2007
- Posted by the FDA
- Dec 4, 2007
- Recalling firm
- Straumann USA LLC
- Quantity
- 58 units
- Product code
- OAT
- FDA submissions
- K060062
- Distribution
- Nationwide Distribution - USA including states of AZ, CA, CO, ID, IL, IN, GA, KY, NH , MA, MD, MI, NM, PA, TX, UT, VA, and WA.
Product description
Straumann Palatal Implant , 04.1 L 4.2 mm, Article Number: 042.335S, Straumann USA., LLC, Andover, Massachusetts, 01810-1008
Code information (models, lots, serial numbers)
Lot Numbers: 1001, F3776, F4662, F6563, E7083
Other devices under the same FDA submission
2 devices cleared under K060062 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- STRAUMANN ORTHOSYSTEM Palatal-SystemInstitut Straumann AG · Implant, endosseous, orthodontic328 reports
- STRAUMANN ORTHOSYSTEM Palatal-SystemInstitut Straumann AG · Implant, endosseous, orthodontic34 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 45420).
- Z-0278-2008 · TerminatedStraumann Palatal Implant , 4.8 L 4.2 mm, Article Number: 042.336S, Straumann USA., LLC, Andover, Massachusetts, 01810-1008
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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